During the project period, there were 29 689 births in the intervention areas and 88 471 births in the control areas. In the intervention area, TBAs carried out antenatal, intrapartum and postnatal care. They were supplied with delivery kits and taught clean delivery. No immunization was performed.

The neonatal tetanus rate decreased by 99% in the intervention area compared to the control area (0.75/1000 live births in intervention areas, range = 0–3, vs 82/1000 live births in control areas, range = 74–93).

Women from 3 districts who had delivered a live infant (defined as a baby that survived at least 24 hours after birth and was born at home between 7 and 28 d prior to the interview) were enrolled in 1 of 4 possible cohorts: 1) kit user with trained attendant (n = 420), 2) kit user with untrained or no attendant (n = 398), 3) kit non-user with trained attendant (n = 404), and 4) kit non-user with untrained or no attendant (n = 438). The data were then collected by interviews with the mothers of the newborns, members of the mother's household who were present for the delivery or were caretakers of the newborn along with some trained TBAs who had participated in some eligible deliveries. Field interviewers also directly observed the newborn's abdomen and cord area, and consulted with medical records if available.

The cohorts in which kits were used had less than half the infection rate (0.45; CI: 0.25–0.81) of kit non-users who did not use a new or boiled blade and clean cutting surface (after adjusting for confounders), but there was no significant difference between kit users and any other group of kit non-users, suggesting that clean cord-cutting is one of the most important practices in preventing infection.

TT vaccination was given IM to pregnant women (n = 1760) as a single booster dose to those who had received 2 doses in the preceding 3 y (n = 762), and TT vaccine was given in 2 doses at 1-month intervals to those who had no previous history of TT immunization (n = 696) or who were previously only partially immunized (n = 230).

Neonatal tetanus prevention attributable to TT vaccine was 88% for complete immunization and 59% for partial immunization compared to nonimmunized. The risk of neonatal tetanus among children born to women who received any dose of TT was one-fifth that of children born to non-immunized mothers (OR: 0.12; CI: 0.02–0.41).

An education program for TBAs (n = 214) consisting of general midwifery and cord-care training was carried out in 2 provinces with a total population of 500 000, and mass TT immunization was carried out in just 1 of the provinces. Pre- and post-intervention surveys were carried out with randomly selected groups of 210 respondents; the project also interviewed 112 TBAs.

The incidence of neonatal tetanus in both provinces declined sharply, suggesting that reinforcement of routine services and hygienic practices was of primary importance. The NNT death rate was 0.2–0.4/1000 at the end of the intervention, reduced 8- to 10-fold.

TT immunization of pregnant women was initiated in 28 villages in 1970. The second strategy adopted in this area after 1982 was to distribute to every registered pregnant women a sterilized delivery kit containing gauze pieces, half a razor blade and thread.

There was a gradual and sustained reduction in the neonatal mortality rate from 42.3/1000 live births in 1972 to 17.9/1000 in 1987. During this period, neonatal deaths due to tetanus disappeared (14.6/1000 live births in 1972, 0/1000 in 1987). A 22% reduction in NMR occurred after the introduction of birth kits; there is a mixed impact of birth kits and TT.

Neonatal mortality was compared between offspring born from 1978–1979 to women who had received TT prior to pregnancy (n = 956), offspring born to women given TT while pregnant from 1978–1979 (n = 934), offspring born to partially immunized women (n = 729), and offspring born to non-immunized mothers (n = 7237). Women given TT were given 2 doses if immunized in 1974 (non-pregnant), 3 doses of TT if immunized in 1978 (pregnant) and 2 doses if immunized in 1979.

Decreases in the stillbirth rate (44%, P < .05) and neonatal mortality rate (49%, P < .01) were observed in the women who were fully immunized in pregnancy compared to those who were not.

In 3 unions, TBAs were trained in better maternal nutrition and hygienic newborn care practices; in 3 unions TT was given; and 3 unions were kept as controls. 1760 pregnant women were cared for by these TBAs.

NMR decreased 72% and 54% in the TBA training areas and the TT areas, respectively. The NMR was 38.9/1000 in TT unions compared to 85.2/1000 in control unions. Tetanus neonatorum decreased by 94.6% in the TT area.

In the first cohort of offspring, neonatal mortality was significantly lower (33%, P < .01) among those born after 9–32 mo of mass tetanus vaccination in women (68.4/1000 in controls vs 44.1/1000 in TT area). 75% of the reduction in mortality was attributable to the reduction in neonatal mortality between 4–14 d of age (P < .001).